SX11
Relapse Management in Relapsing-Remitting Multiple Sclerosis (RRMS): Results from a Real-World Analysis of Treatment Patterns

Thursday, June 2, 2016
Exhibit Hall
Robert J Fox, MD, FAAN , Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH
David Templeton, MBA , Medical Data Analytics, Parsippany, NJ
Beth Lesher, PharmD, BCPS , Pharmerit International, Bethesda, MD
Manoj Malhotra, MD , Autoimmune and Rare Diseases, Mallinckrodt Pharmaceuticals, Hayward, CA
Beth Lesher, PharmD, BCPS , Pharmerit International, Bethesda, MD



Background: Real-world data are lacking for relapse management in RRMS.

Objectives: We examined characteristics and treatment patterns of relapsed RRMS patients.

Methods: Academic/community-based neurologists (N=106) participated in a retrospective chart review of 3 recent relapses (≥1 in ≤12 months) for 310 randomly selected adults with RRMS from their clinical practice. Disease/relapse severity was measured on a scale of 1 (mild) to 3 (severe).

Results: Characteristics were similar regardless of disease severity at diagnosis. Most patients were Caucasian (76.8%) and female (68.7%); mean age was 40.3 years and annual relapse rate 1.0. Most relapses (N = 930) were of mild (44.6%) or moderate (47.2%) intensity with a mean of 2.9 symptoms. Relapse severity was higher for patients diagnosed with more severe disease (P<0.01). Motor or cerebellar (loss of balance, weakness of limbs, gait ataxia, muscle spasms/stiffness; P<0.0001 for all) but not sensory (numbness, paresthesia/tingling sensation) or constitutional (fatigue, dizziness) symptoms increased with increasing relapse severity. One course of therapy was administered for 73.1% of relapses. Relapse treatments were IV (61.8%)/oral (23.1%) steroids, corticotropin (10.3%), or other (4.7%). Mean treatment duration for IV steroids was 5.1, oral steroids 15.5, and corticotropin 9.3 days. Relapses treated with vs without IV steroids (1.9 vs 1.4; P<0.001) or corticotropin (1.9 vs 1.6; P<0.001) were of higher severity. Relapses treated with vs without oral steroids were of lower severity (1.5 vs 1.7; P=0.009). Mean symptom number for relapses treated with vs without IV steroids was 3.2 vs 2.5 (P<0.001); corticotropin 3.6 vs 2.8 (P<0.01); and oral steroids 2.9 vs 2.9 (P=0.095). At relapse end, patients treated with vs without IV steroids (84.0% vs 68.7%; P<0.0001) but not corticotropin (80.0% vs 76.7%; P=0.5) or oral steroids (77.2% vs 76.9%; P=0.9) had more unresolved symptoms.

Conclusions: Mean relapse severity increased with increasing disease severity at diagnosis. Motor and cerebellar, but not sensory and constitutional symptoms, increased with increasing relapse severity. Patients treated with vs without IV steroids had more severe relapses and unresolved symptoms at relapse end, patients treated with vs without corticotropin had more severe relapses and fewer unresolved symptoms at relapse end, and patients treated with vs without oral steroids had less severe relapses and fewer unresolved symptoms at relapse end.